- GRAIL (Durham, NC)
- …filings. + Manage the creation and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties ... For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal… more
- Parexel (Raleigh, NC)
- …markets? Parexel is seeking an experienced and highly motivated **Global Regulatory Labeling Lead** to provide strategic leadership and operational oversight for ... This role is integral to the development, governance, and maintenance of regulatory labeling content that supports the safe and effective use of products… more
- Organon & Co. (Raleigh, NC)
- …Own it, Rise together and Keep moving. + Ensures proper diligence on policy , legal, regulatory , and company compliance issues. **Required Education, Experience ... and Skills** + BA/BS. + Two plus years of managed care account manager or equivalent experience. + Customer knowledge and/or regional/national health plan knowledge. + Strong communication, presentation, and consultative selling skills with executive presence.… more
- ITG Brands (Greensboro, NC)
- …executing, and interpreting behavioral and human factors research to support regulatory submissions, including PMTAs. This role focuses on understanding consumer ... impact. The ideal candidate brings deep expertise in behavioral science, regulatory strategy, and cross-functional collaboration to ensure all behavioral data meets… more
- ITG Brands (Greensboro, NC)
- …JOB SUMMARY The Senior Toxicologist plays a pivotal role in shaping regulatory strategy and scientific direction for tobacco product submissions, including Premarket ... DO Lead the development of toxicology strategies for PMTA and other regulatory submissions, ensuring alignment with FDA expectations and public health standards.… more
- GRAIL (Durham, NC)
- …process optimization experience, and a thorough understanding of clinical laboratory regulatory frameworks. This position is **onsite full-time** , with **5 days ... and quality. + Prepare comprehensive technical documentation, scientific reports, and regulatory submission materials as required. + Maintain high standards of… more
- ITG Brands (Greensboro, NC)
- …(EOL), to ensure delivery of business objectives. Accountable for ensuring US Regulatory & Compliance requirements are met for all specifications across all Company ... Lead team functioning as point of contact for US regulatory product compliance for all US marketed products and.../ in office - Summer hours - Casual dress policy Monday through Friday **Applicant Information** This job description… more
- Endo International (Raleigh, NC)
- …for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards. This role involves managing QC ... QC policies, SOPs, and testing protocols in compliance with GMP and regulatory guidelines.** + **Oversee analysis of raw materials, in-process samples, and finished… more
- Ally (Raleigh, NC)
- …* Develop and implement comprehensive fraud prevention controls, including policy formulation, setting limits, and establishing validation controls throughout the ... industry forums to remain at the forefront of fraud prevention practices and regulatory changes. * Collaborate with senior leadership to develop business cases and… more
- ITG Brands (Greensboro, NC)
- …and Product data management + Manages and maintains material/product regulatory compliance documentation in central specification system ensuring record completion ... BoMs and specifications to production facilities to assure compliance with regulatory requirements and accuracy and integrity of all product specifications. +… more
